Wockhardt's Zaynich Receives Favourable Recommendation from CDSCO for Treatment of Gram-Negative Infections

Wockhardt Limited has announced that its novel antibiotic, Zaynich (Zidebactam/Cefepime), has received a favourable recommendation from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) for the treatment of Gram-negative infections. This positive opinion brings Zaynich closer to final approval by the Drugs Controller General of India (DCGI). The recommendation follows a comprehensive review of the product dossier, including non-clinical data, nine Phase 1 studies, a multi-indication Phase 2 study in meropenem-resistant infections, a global Phase 3 study in complicated urinary tract infections and acute pyelonephritis, and data from 85 compassionate-use cases. Zaynich, developed over 15 years, features a novel β-lactam enhancer-based mechanism, potentially offering unprecedented coverage of MDR/XDR Gram-negative pathogens prevalent in India. It is one of the most comprehensively evaluated antibiotics globally in recent years, with over 100 national and international publications and presentations. Zaynich has demonstrated superiority over meropenem in combined clinical and microbiological cure in the Phase 3 study, and showed over 97% clinical efficacy in a real-world study of meropenem-resistant infections in India. It also demonstrated strong efficacy in 85 XDR Gram-negative infection cases treated under compassionate use in India, US, Malaysia, and France. A New Drug Application (NDA) in the United States and a Marketing Authorisation Application (MAA) in the European Union for Zidebactam/Cefepime have been submitted and are currently in the advanced stages of review.